Home NDC 84126-324 Rolaids ORIGINAL
Product NDC 84126-324
11-digit product format 841260324
Labeler code 84126
Product ID 84126-324_5cdae69c-4d70-c3f5-e063-6394a90ad5cc
Type HUMAN OTC DRUG
Nonproprietary name Calcium carbonate and Magnesium hydroxide
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler THE PROCTER & GAMBLE MANUFACTURING COMPANY
Application M001
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-09
Substance CALCIUM CARBONATE; MAGNESIUM HYDROXIDE
Active strength 675; 135 mg/1; mg/1
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Rolaids ORIGINAL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCIUM CARBONATE 675 mg/1 MAGNESIUM HYDROXIDE 135 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84126-324-01 Rolaids ORIGINAL 10 in 1 PACKAGE TABLET, CHEWABLE 10 3 84126-324-03 Rolaids ORIGINAL 3 in 1 CELLO PACK TABLET, CHEWABLE 3 3 84126-324-96 Rolaids ORIGINAL 96 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 96 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84126-324 ROLAIDS ORIGINAL (CALCIUM CARBONATE AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 1 Current NDC, 3 package rows 20241211_28d9b359-ae44-2c87-e063-6394a90a22f0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 34 · 678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84126-324-01 84126032401 10 in 1 PACKAGE Historical 84126-324-03 84126032403 3 PACKAGE in 1 CELLO PACK (84126-324-03) / 10 TABLET, CHEWABLE in 1 PACKAGE (84126-324-01) 3 package 2024-12-09 No No Current 84126-324-96 84126032496 96 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (84126-324-96) 2024-12-09 No No Current